Table 3 Interim Analysis
Subject | Regimen | Reviewer’s Assessment | Score |
|---|---|---|---|
2000 | 50 Gy/25 Fx Boost 10 Gy/5 Fx | Grade 2 dermatitis and Grade 1 folliculitis on treatment day 25. On boost day 5, the dermatitis in the axilla had improved. The SDAS showed an area of protection. | ++ |
2001 | 45 Gy/25 Fx, Boost 16 Gy/8 Fx | On boost day 5, Grade 1 dermatitis in the posterior axilla with Grade 2 dry desquamation in the anterior axilla. At Follow-up, the SDAS showed a subtle decrease in dermatitis relative to the rest of the axilla. Treatment benefit evident late. | ++ |
2002 | 50.4 Gy/28 Fx, Boost 10 Gy/5 Fx | On treatment day 25 there was an area of Grade 2 dry desquamation just outside of the SDAS. The drug may have prevented desquamation in the SDAS | + |
2003 | 50.5 Gy/25 Fx | Grade 1 dermatitis with an area of Grade 2 dry desquamation in the axilla, adjacent to the SDAS. The axilla had less dermatitis than expected; the SDAS was Grade 0. | +++ |
2004 | 50 Gy/25 Fx, Boost 10 Gy/5 Fx | SDAS had a response that was evident on treatment day 23 and obvious on boost day 5, when there was Grade 0 dermatitis in the SDAS vs Grade 1-2 elsewhere. | +++ |
2005 | 42.66 Gy/16 Fx, Boost, 8 Gy/4 Fx | Grade 1 dermatitis. On boost day 4, an area in the axilla looked dusky, as if there was about to be a skin breakdown. At week 4 follow-up, the SDAS seemed to have improved more than other areas | + |
2006 | 50.4 Gy/28 Fx, Boost 10 Gy/5 | At week 1 follow-up, Grade 1 dermatitis in the axilla and Grade 2 dermatitis above the nipple. Obvious reduction in the SDAS, subtle on boost day 2 and obvious at week 1 follow-up, when there was Grade 0 dermatitis and a clear response relative to the rest of the breast. | +++ |
2007 | 42.66 Gy/16 Fx | Grade 1 radiodermatitis and folliculitis. No changes in the SDAS on day 15, but a subtle improvement at week 1 follow-up. | + |
2008 | 42.56 Gy/16 Fx, Boost 8 Gy/4 Fx | Very mild grade 1 radiodermatitis on the breast and in the axilla. | 0 |